Avaí Bio, Inc. develops cell-based therapies centered on genetically modified cell lines, protective encapsulation technologies and joint venture or licensing structures. The company, formerly Avant Technologies Inc., uses the AVAI ticker and has described a biotechnology focus spanning diabetes, age-related disorders and anti-aging applications.
Recurring developments include the Insulinova diabetes program, which pairs insulin-producing or regulating cells with encapsulation technology, and the Klothonova α-Klotho program, which uses encapsulated cells designed to produce the longevity protein α-Klotho. Company updates also cover GMP manufacturing steps such as master cell bank production, research presentations, partner collaborations and the completed corporate name change to Avaí Bio.
Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech are exploring the integration of early dementia detection into Ainnova's Vision AI platform. The companies are considering either licensing or acquiring a patented technology that uses AI algorithms and hardware for dementia detection through a 5-minute blood test.
The Vision AI platform currently employs 4 integrated algorithms to assess risks for cardiovascular disease, type 2 diabetes, liver fibrosis, and chronic kidney disease using retinal images, blood pressure, and lab test data. The system utilizes an automated, low-cost retinal imaging device for comprehensive preventive risk screening.
Avant Technologies (OTCQB: AVAI) and Ainnova Tech have entered acquisition negotiations to strengthen their position in the AI-driven healthcare industry. The companies, which formed Ai-nova Acquisition Corp (AAC) six months ago, are looking to consolidate before their FDA pre-submission meeting in July 2025 regarding clinical trials for the Vision AI platform in diabetic retinopathy detection.
AAC currently holds worldwide licensing rights for Ainnova's technology portfolio, which includes the Vision AI platform and retinal cameras. The proposed merger aims to streamline the advancement of their technology to market and enhance resource utilization. The companies believe consolidating operations will facilitate their FDA interactions and accelerate their entry into the U.S. market.
Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech have secured a pre-submission meeting with the FDA scheduled for July 7, 2025. The meeting will discuss their planned clinical trial for the Vision AI platform, designed for early detection of diabetic retinopathy. Through Ai-nova Acquisition Corp. (AAC), formed by the partnership, the companies aim to determine crucial trial parameters including the number of clinical sites, patient count, and protocol approval.
The meeting represents a significant step toward obtaining FDA 510(k) clearance for U.S. market entry. AAC holds worldwide licensing rights for Ainnova's technology portfolio, making successful FDA interactions crucial for commercialization in the United States market.
Avant Technologies (OTCQB: AVAI) and its joint venture partner Ainnova Tech have reached a significant milestone in their regulatory journey by requesting a pre-submission meeting with the FDA for their VisionAI platform technology.
The technology, focused on early detection of diabetic retinopathy, will be reviewed by the FDA's Center for Devices and Radiological Health. The companies aim to obtain FDA 510(k) clearance to market the technology in the U.S. through their partnership entity, Ai-nova Acquisition Corp (AAC).
Key points:
- AAC holds worldwide licensing rights for VisionAI platform and retinal cameras
- The strategy includes rapid deployment in low-regulation markets while pursuing FDA clearance
- Pre-submission meeting will help determine clinical trial requirements and budget planning
- Success with FDA is crucial for U.S. market entry and commercial potential
Avant Technologies (OTCQB: AVAI) and its partner Ainnova Tech are expanding their joint venture, Ai-nova Acquisition Corp (AAC), across Latin America following Ainnova's participation in the 2025 Healthcare Innovation Summit in Mexico City. The expansion includes commercial pilots in Chile and Dominican Republic hospitals, focusing on demonstrating cost reduction in preventive diagnostics and improved healthcare efficiency.
The pilots utilize Ainnova's Vision AI platform for real-time health risk identification, enabling specialty care referrals. The joint venture plans to deploy an automated retinal imaging device integrated with AI to screen for cardiovascular disease, type 2 diabetes, liver fibrosis, and chronic kidney disease using retinal images and basic health data.
AAC holds global licensing rights for Ainnova's technology portfolio. The companies are pursuing regulatory approvals in Brazil through MDSAP certification for ANVISA requirements, while simultaneously preparing for FDA clinical trials in the United States.
Avant Technologies (OTCQB: AVAI) and its partner Ainnova Tech announced that Ainnova will sponsor and present at the 2025 Healthcare Innovation Summit in Mexico City. Ainnova's CEO Vinicio Vargas will deliver a presentation titled 'Preventative Healthcare with Artificial Intelligence: Breaking the Status Quo.'
The companies have formed Ai-nova Acquisition Corp. (AAC), which holds global licensing rights for Ainnova's technology portfolio, including its Vision AI platform and retinal cameras. The Healthcare Innovation Summit Series is a global event bringing together key stakeholders such as government officials, regulators, hospital administrators, and clinical experts to discuss healthcare transformation, systems optimization, and digital innovation.
Avant Technologies (OTCQB: AVAI) and its partner Ainnova Tech have initiated the design of clinical trial protocols for their Vision AI platform, focusing on early detection of diabetic retinopathy. The companies are preparing for a pre-submission meeting with the FDA scheduled for mid-May 2025, which will guide the clinical testing requirements for their 510(k) clearance application.
An ophthalmologist has been hired to assist in drafting the trial protocol requirements requested by their Contract Research Organization (CRO), Fortrea. The technology is being developed through Ai-nova Acquisition Corp. (AAC), a joint venture holding global licensing rights to Ainnova's technology portfolio, including the Vision AI platform and retinal cameras.
The FDA pre-submission program will help determine the regulatory pathway, including patient and clinic requirements for clinical data generation, and enable Avant to establish a precise budget for the FDA process.
Avant Technologies (OTCQB:AVAI) and its partner Ainnova Tech have announced a strategic collaboration with Apollo Hospitals to advance AI in healthcare. Ainnova has secured exclusive licenses for AI algorithms validated with over 2.3 million data points for their Vision AI platform.
The platform enables early detection of various conditions including cardiovascular disease, chronic kidney disease, liver fibrosis, type 2 diabetes, and lung abnormalities. Following Avant and Ainnova's recent global development deal through their joint venture AAC, the AI diagnostics will be launched commercially across the Americas in the coming weeks.
The partnership has already received regulatory approval from ANVISA for expansion into Brazil's 200-million-person market. The collaboration aims to enhance chronic disease management by facilitating early referrals from primary care providers and community health services to specialists.